Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7080 | Drug | This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | Up to 4 weeks | |
| Number of Participants With Adverse Events | Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS). | Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days). |
Not provided
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tatsuya Sasaki | Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuo-ku | Tokyo | Japan |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | E7080 | E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E7080 | E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) | Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT. | Posted | Number | Participants | Up to 4 weeks |
|
|
Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E7080 | E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatsuya Sasaki | Eisai Co., Ltd. | 81-3-3817-5252 | 5252 |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Participants |
|
|
| Primary | Number of Participants With Adverse Events | Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS). | The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Posted | Number | Participants | Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days). |
|
|
|
| 1 |
| 9 |
| 9 |
| 9 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA version 15.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Occult blood | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
Not provided